Testing the Lily Device for reducing hair loss during chemotherapy

PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.

This study is testing the Lily Device to see if it can help women with breast cancer keep their hair during chemotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Luminate Medical, Inc. (industry)
• Drugs / interventions: trastuzumab, pertuzumab, pembrolizumab, chemotherapy, immunotherapy, cyclophosphamide, Doxorubicin
• Locations: 5 sites (Mullica Hill, New Jersey and 4 other locations)
• Trial ID: NCT06786078 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Lily Device in reducing hair loss caused by chemotherapy in patients with breast cancer. Participants will use the device during their chemotherapy treatment, and the study will assess hair preservation after four cycles of chemotherapy. Additionally, the trial will monitor the safety of the device by tracking any adverse events related to its use. The primary outcome will be the preservation of hair as graded by healthcare professionals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage 1, 2, or 3 breast cancer who are about to start chemotherapy.

Not a fit: Patients who are not undergoing chemotherapy or have already started systemic therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this device could help patients maintain their hair during chemotherapy, improving their quality of life.

How similar studies have performed: While there have been various approaches to managing chemotherapy-induced hair loss, the specific use of the Lily Device is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥ age 18 with breast cancer stage 1, 2 or 3, who have been deemed appropriate for (neo-)adjuvant chemotherapy and have not yet begun any systemic therapy.
2. Planned intravenous chemotherapy in the adjuvant or neoadjuvant setting with at least 4 cycles of chemotherapy, with one of the following regimens:

   * Doxorubicin 60 mg/m\^2 with cyclophosphamide 600 mg/m\^2 every 2-3 weeks
   * Doxorubicin 60 mg/m\^2 with fluorouracil 500 mg/m\^2 and cyclophosphamide 500 mg/m\^2 every 2-3 weeks
   * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle)
   * Paclitaxel 175 mg/m\^2 every 2-3 weeks
   * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 1.5 every week
   * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 5-6 every 3 weeks
   * Docetaxel 75-100 mg/m\^2 every 3 weeks
   * Docetaxel 75 mg/m\^2 with cyclophosphamide 600 mg/m\^2 every 3 weeks
   * Docetaxel 75 mg/m\^2 with carboplatin AUC 5-6 every 3 weeks

     * Concurrent administration with targeted agents/immunotherapy at standard doses (such as trastuzumab, pertuzumab, pembrolizumab) is allowed. Duration of targeted agents/immunotherapy is at the investigator's discretion.
     * Participants on AC-T regimens who are prescribed with at least 4 treatments with anthracycline followed by at least 4 treatments with taxane are eligible for the study. In terms of data analysis, these participants are counted towards the anthracycline group
3. Head size within the specified study sizing range.
4. Plan to complete chemotherapy in ≤ 12 months.
5. Willing and able to sign informed consent.
6. Willing to comply and tolerate all study procedures including:

   * Wearing the Lily device for the prescribed duration (device to be fitted before chemotherapy infusion, and worn during infusion and for at least two (2) hours and up to four (4) hours post infusion),
   * Complete all study related questionnaires.
   * Having photographs taken of the head at each visit.

To note:

* Participants who experience a hypersensitivity reaction to chemotherapy are allowed to continue in the study if the standard doses are maintained.
* Participants on the chemotherapy plan KEYNOTE-522 are eligible for this study.
* If a participant is prescribed a different chemotherapy treatment plan, they may be eligible for the study only if prior Sponsor approval is obtained.

Exclusion Criteria:

1. Baseline alopecia defined as CTCAE v5.0 grade \> 0.
2. History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus.
3. History of whole brain irradiation.
4. Recent chemotherapy (≤ 2 years), which caused hair loss.
5. Participants who are receiving or are planning to receive hormone replacement therapy or anti-estrogen therapy during the study, whereby the therapy in question has a known profile for causing hair loss.
6. Prescribed chemotherapy regimen with concurrent administration of taxane-based and anthracycline-based chemotherapy (i.e., infusion of both taxane and anthracycline agents on the same day).
7. Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient.
8. Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant.
9. Participants with a history of Temporomandibular Joint Disorder.
10. Any open wounds or sores on the participant's scalp or on part of the face where the device will be applied, which in the opinion of the investigator will not be healed prior to chemotherapy commencing.
11. Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy.
12. Intercurrent life-threatening malignancy.
13. An existing history of scalp metastases or suspicion of presence of scalp metastasis.
14. Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study.
15. Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study.
16. Participants who do not have the mental or physical ability to comply with time schedules and further study procedures.
17. Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss.
18. Participation in this study at an earlier stage.

Where this trial is running

Mullica Hill, New Jersey and 4 other locations

• Inspira Health - Mullica Hills — Mullica Hill, New Jersey, United States (RECRUITING)
• Inspire Health - Vineland — Vineland, New Jersey, United States (RECRUITING)
• Guthrie - Our Lady of Lourdes Memorial Hospital — Binghamton, New York, United States (RECRUITING)
• Clinical Research Alliance — Westbury, New York, United States (RECRUITING)
• Guthrie Sayer Medical Centre — Sayre, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Kimberly Wilkinson

Conditions: Chemotherapy Induced Alopecia